Release 5 Draft Ballot

This page is part of the FHIR Specification (v4.6.0: R5 Draft Ballot). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

Codesystem-state-change-reason.xml

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: Informative

Raw XML (canonical form + also see XML Format Specification)

Definition for Code System StateChangeReason

<?xml version="1.0" encoding="UTF-8"?>

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="state-change-reason"/> 
  <meta> 
    <lastUpdated value="2021-04-15T13:25:09.461+11:00"/> 
    <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> 
  </meta> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p> This code system http://terminology.hl7.org/CodeSystem/state-change-reason defines the
         following codes:</p> 
      <table class="codes">
        <tr> 
          <td style="white-space:nowrap">
            <b> Code</b> 
          </td> 
          <td> 
            <b> Display</b> 
          </td> 
          <td> 
            <b> Definition</b> 
          </td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">adverseEvent
            <a name="state-change-reason-adverseEvent"> </a> 
          </td> 
          <td> adverse event</td> 
          <td> adverse event.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">death
            <a name="state-change-reason-death"> </a> 
          </td> 
          <td> death (adverse event)</td> 
          <td> death (adverse event).</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">notEligible
            <a name="state-change-reason-notEligible"> </a> 
          </td> 
          <td> did not meet eligibility criteria</td> 
          <td> did not meet eligibility criteria.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">eligibleButNo
            <a name="state-change-reason-eligibleButNo"> </a> 
          </td> 
          <td> eligible but unwilling or unable to participate</td> 
          <td> eligible but unwilling or unable to participate.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">enrolled
            <a name="state-change-reason-enrolled"> </a> 
          </td> 
          <td> enrolled or registered</td> 
          <td> enrolled or registered.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">exclusion
            <a name="state-change-reason-exclusion"> </a> 
          </td> 
          <td> exclusion</td> 
          <td> exclusion.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">followUpComplete
            <a name="state-change-reason-followUpComplete"> </a> 
          </td> 
          <td> follow-up complete</td> 
          <td> follow-up complete.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">inclusion
            <a name="state-change-reason-inclusion"> </a> 
          </td> 
          <td> inclusion</td> 
          <td> inclusion.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">informedConsentSigned
            <a name="state-change-reason-informedConsentSigned"> </a> 
          </td> 
          <td> Informed consent signed</td> 
          <td> Informed consent signed.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">intOrObsComplete
            <a name="state-change-reason-intOrObsComplete"> </a> 
          </td> 
          <td> intervention or observation complete</td> 
          <td> intervention or observation complete.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">nonCompliance
            <a name="state-change-reason-nonCompliance"> </a> 
          </td> 
          <td> non-compliance</td> 
          <td> non-compliance.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">preReg
            <a name="state-change-reason-preReg"> </a> 
          </td> 
          <td> pre-registered or slot reserved</td> 
          <td> pre-registered or slot reserved.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">refuseConsent
            <a name="state-change-reason-refuseConsent"> </a> 
          </td> 
          <td> refuse consent</td> 
          <td> refuse consent.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">screenFailure
            <a name="state-change-reason-screenFailure"> </a> 
          </td> 
          <td> screen failure</td> 
          <td> screen failure.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">studyClosed
            <a name="state-change-reason-studyClosed"> </a> 
          </td> 
          <td> study permanently closed to accrual</td> 
          <td> study permanently closed to accrual.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">studyTerminated
            <a name="state-change-reason-studyTerminated"> </a> 
          </td> 
          <td> study terminated</td> 
          <td> study terminated.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">subjectRefusal
            <a name="state-change-reason-subjectRefusal"> </a> 
          </td> 
          <td> subject refusal</td> 
          <td> subject refusal.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">unwillingOrUnable
            <a name="state-change-reason-unwillingOrUnable"> </a> 
          </td> 
          <td> unwilling or unable to participate</td> 
          <td> unwilling or unable to participate.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">withdrawnConsent
            <a name="state-change-reason-withdrawnConsent"> </a> 
          </td> 
          <td> withdrawn consent</td> 
          <td> withdrawn consent.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">diseaseRelapse
            <a name="state-change-reason-diseaseRelapse"> </a> 
          </td> 
          <td> Disease Relapse</td> 
          <td> Relapse of disease.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">failedRandomization
            <a name="state-change-reason-failedRandomization"> </a> 
          </td> 
          <td> Failed Randomization</td> 
          <td> Subject failed randomization.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">lackOfEfficacy
            <a name="state-change-reason-lackOfEfficacy"> </a> 
          </td> 
          <td> Lack Of Efficacy</td> 
          <td> The study activities were not efficient in dealing with the underlying issue.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">lostToFollowUp
            <a name="state-change-reason-lostToFollowUp"> </a> 
          </td> 
          <td> Lost To Follow Up</td> 
          <td> The subject can no longer be followed up.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">physicianDecision
            <a name="state-change-reason-physicianDecision"> </a> 
          </td> 
          <td> Physician Decision</td> 
          <td> A physician has decided the subject should no longer continue on the study.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">pregnancy
            <a name="state-change-reason-pregnancy"> </a> 
          </td> 
          <td> Pregnancy</td> 
          <td> Subject is now pregnant and no longer meets the inclusion criteria.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">progressiveDisease
            <a name="state-change-reason-progressiveDisease"> </a> 
          </td> 
          <td> Progressive Disease</td> 
          <td> The subject has a disease that has progressed to far to allow them to continue in the
             study.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">protocolDeviation
            <a name="state-change-reason-protocolDeviation"> </a> 
          </td> 
          <td> Protocol Deviation</td> 
          <td> There has been a protocol deviation that cannot be corrected or compensated for.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">recovery
            <a name="state-change-reason-recovery"> </a> 
          </td> 
          <td> Recovery</td> 
          <td> The subject has recovered and no longer meets the inclusion criteria.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">siteTerminated
            <a name="state-change-reason-siteTerminated"> </a> 
          </td> 
          <td> Site Terminated</td> 
          <td> The site where the subject was being treated is no longer in the study.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">technicalProblems
            <a name="state-change-reason-technicalProblems"> </a> 
          </td> 
          <td> Technical Problems</td> 
          <td> The subject cannot continue on the study due to technical issues.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">complete
            <a name="state-change-reason-complete"> </a> 
          </td> 
          <td> Complete</td> 
          <td> The study is now complete.</td> 
        </tr> 
      </table> 
    </div> 
  </text> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="draft"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/> 
  </extension> 
  <url value="http://terminology.hl7.org/CodeSystem/state-change-reason"/> 
  <identifier> 
    <system value="urn:ietf:rfc:3986"/> 
    <value value="urn:oid:2.16.840.1.113883.4.642.1.1477"/> 
  </identifier> 
  <version value="4.6.0"/> 
  <name value="StateChangeReason"/> 
  <title value="StateChangeReason"/> 
  <status value="draft"/> 
  <experimental value="false"/> 
  <date value="2020-12-28T16:55:11+11:00"/> 
  <publisher value="HL7 (FHIR Project)"/> 
  <contact> 
    <telecom> 
      <system value="url"/> 
      <value value="http://hl7.org/fhir"/> 
    </telecom> 
    <telecom> 
      <system value="email"/> 
      <value value="fhir@lists.hl7.org"/> 
    </telecom> 
  </contact> 
  <description value="Indicates why the state of the subject changed."/> 
  <caseSensitive value="true"/> 
  <valueSet value="http://hl7.org/fhir/ValueSet/state-change-reason"/> 
  <content value="complete"/> 
  <concept> 
    <code value="adverseEvent"/> 
    <display value="adverse event"/> 
    <definition value="adverse event."/> 
  </concept> 
  <concept> 
    <code value="death"/> 
    <display value="death (adverse event)"/> 
    <definition value="death (adverse event)."/> 
  </concept> 
  <concept> 
    <code value="notEligible"/> 
    <display value="did not meet eligibility criteria"/> 
    <definition value="did not meet eligibility criteria."/> 
  </concept> 
  <concept> 
    <code value="eligibleButNo"/> 
    <display value="eligible but unwilling or unable to participate"/> 
    <definition value="eligible but unwilling or unable to participate."/> 
  </concept> 
  <concept> 
    <code value="enrolled"/> 
    <display value="enrolled or registered"/> 
    <definition value="enrolled or registered."/> 
  </concept> 
  <concept> 
    <code value="exclusion"/> 
    <display value="exclusion"/> 
    <definition value="exclusion."/> 
  </concept> 
  <concept> 
    <code value="followUpComplete"/> 
    <display value="follow-up complete"/> 
    <definition value="follow-up complete."/> 
  </concept> 
  <concept> 
    <code value="inclusion"/> 
    <display value="inclusion"/> 
    <definition value="inclusion."/> 
  </concept> 
  <concept> 
    <code value="informedConsentSigned"/> 
    <display value="Informed consent signed"/> 
    <definition value="Informed consent signed."/> 
  </concept> 
  <concept> 
    <code value="intOrObsComplete"/> 
    <display value="intervention or observation complete"/> 
    <definition value="intervention or observation complete."/> 
  </concept> 
  <concept> 
    <code value="nonCompliance"/> 
    <display value="non-compliance"/> 
    <definition value="non-compliance."/> 
  </concept> 
  <concept> 
    <code value="preReg"/> 
    <display value="pre-registered or slot reserved"/> 
    <definition value="pre-registered or slot reserved."/> 
  </concept> 
  <concept> 
    <code value="refuseConsent"/> 
    <display value="refuse consent"/> 
    <definition value="refuse consent."/> 
  </concept> 
  <concept> 
    <code value="screenFailure"/> 
    <display value="screen failure"/> 
    <definition value="screen failure."/> 
  </concept> 
  <concept> 
    <code value="studyClosed"/> 
    <display value="study permanently closed to accrual"/> 
    <definition value="study permanently closed to accrual."/> 
  </concept> 
  <concept> 
    <code value="studyTerminated"/> 
    <display value="study terminated"/> 
    <definition value="study terminated."/> 
  </concept> 
  <concept> 
    <code value="subjectRefusal"/> 
    <display value="subject refusal"/> 
    <definition value="subject refusal."/> 
  </concept> 
  <concept> 
    <code value="unwillingOrUnable"/> 
    <display value="unwilling or unable to participate"/> 
    <definition value="unwilling or unable to participate."/> 
  </concept> 
  <concept> 
    <code value="withdrawnConsent"/> 
    <display value="withdrawn consent"/> 
    <definition value="withdrawn consent."/> 
  </concept> 
  <concept> 
    <code value="diseaseRelapse"/> 
    <display value="Disease Relapse"/> 
    <definition value="Relapse of disease."/> 
  </concept> 
  <concept> 
    <code value="failedRandomization"/> 
    <display value="Failed Randomization"/> 
    <definition value="Subject failed randomization."/> 
  </concept> 
  <concept> 
    <code value="lackOfEfficacy"/> 
    <display value="Lack Of Efficacy"/> 
    <definition value="The study activities were not efficient in dealing with the underlying issue."/> 
  </concept> 
  <concept> 
    <code value="lostToFollowUp"/> 
    <display value="Lost To Follow Up"/> 
    <definition value="The subject can no longer be followed up."/> 
  </concept> 
  <concept> 
    <code value="physicianDecision"/> 
    <display value="Physician Decision"/> 
    <definition value="A physician has decided the subject should no longer continue on the study."/> 
  </concept> 
  <concept> 
    <code value="pregnancy"/> 
    <display value="Pregnancy"/> 
    <definition value="Subject is now pregnant and no longer meets the inclusion criteria."/> 
  </concept> 
  <concept> 
    <code value="progressiveDisease"/> 
    <display value="Progressive Disease"/> 
    <definition value="The subject has a disease that has progressed to far to allow them to continue in the
     study."/> 
  </concept> 
  <concept> 
    <code value="protocolDeviation"/> 
    <display value="Protocol Deviation"/> 
    <definition value="There has been a protocol deviation that cannot be corrected or compensated for."/> 
  </concept> 
  <concept> 
    <code value="recovery"/> 
    <display value="Recovery"/> 
    <definition value="The subject has recovered and no longer meets the inclusion criteria."/> 
  </concept> 
  <concept> 
    <code value="siteTerminated"/> 
    <display value="Site Terminated"/> 
    <definition value="The site where the subject was being treated is no longer in the study."/> 
  </concept> 
  <concept> 
    <code value="technicalProblems"/> 
    <display value="Technical Problems"/> 
    <definition value="The subject cannot continue on the study due to technical issues."/> 
  </concept> 
  <concept> 
    <code value="complete"/> 
    <display value="Complete"/> 
    <definition value="The study is now complete."/> 
  </concept> 
</CodeSystem> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.